System for securing sutures, grafts and soft tissue to bone and periosteum

ABSTRACT

Self-anchoring slings and deployment mechanisms for use therewith in selectively positioning a sling into position within the body. According to a preferred embodiment, the sling comprises an elongate sling portion having opposed ends. Formed upon each respective opposed end is an anchor member operative to be advanced through soft tissue at a selected target site in a first direction but resist movement in an opposed direction. Such anchor members are operative to extend in opposed directions to thus enable a sling to be securely affixed into position and resist sag or otherwise lose its ability to support a given structure. The deployment system is operative to selectively anchor the respective anchor members into position within a tissue mass. Although suitable for a wide variety of applications, it is believed that the system and sling of the present invention are particularly well suited for the deployment of suburethral slings via a trans-obturator route.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The following patent application is a continuation-in-part ofU.S. patent application Ser. No. 10/466,330 entitled SYSTEMS FORSECURING SUTURES, GRAFTS AND SOFT TISSUE TO BONE A PERIOSTEUM, filedAug. 23, 2003, which is a continuation-in-part of U.S. patentapplication Ser. No. 09/733,455 entitled SYSTEM AND METHOD FOR SECURINGSUTURES TO BONE AND TISSUE, filed Dec. 8, 2000, which is acontinuation-in-part of U.S. patent application Ser. No. 09/197,938entitled SYSTEMS FOR SECURING SUTURES, GRAFTS AND SOFT TISSUE TO BONEAND PERIOSTEUM, now issued as U.S. Pat. No. 6,200,330, and furtherrelies upon Disclosure Document No. 463,908 entitled TransvaginalRectus-Fascia Anchor, filed Oct. 21, 1999; Disclosure Document No.479243 entitled Adjustable Soft Tissue Attachment Device and System,filed Sep. 5, 2000; Disclosure Document entitled TransvaginalRectus-Fascia Attachment, filed Mar. 1, 2000, disclosure document numbernot assigned; Disclosure Document entitled Transvaginal AttachmentDelivery Tool, filed on or about Mar. 1, 2000, disclosure documentnumber not assigned; Disclosure Document No. 463,825 entitledTransvaginal Anchor Delivery Tool, filed on Oct. 21, 1999; DisclosureDocument No. 458,659 entitled Transvaginal Adjustable System, filed Jul.6, 1999; and Disclosure Document No. 480,805 entitled Adjustable SutureSoft Tissue Attachment System, filed Oct. 6, 2000, the teachings of allof which are incorporated herein by reference.

STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT

[0002] Not Applicable

BACKGROUND OF THE INVENTION

[0003] The use of surgical suture anchors for use in attaching softtissue to bone is well known in the art. In this regard, such anchoringmechanisms have found widespread applicability for a number of surgicalprocedures, and in particular orthopedic, gynecologic and urologicprocedures. Exemplary of such devices include bone screws or anchorsthat are implantable within bone which further have formed thereon aneyelet or other type of assembly to which may be affixed suture lines ora segment of soft tissue. Exemplary of such devices include thosedevices disclosed in U.S. Pat. No. 5,370,662, and 5,443,482 to Stone, etal. and U.S. Pat. No. 4,738,255 to Gobel, et al.

[0004] Generally, prior art anchor systems take one of two forms. Thefirst configuration typically comprises a self-tapping bone screw,typically made of titanium, having an eyelet formed thereon to which thesutures or other material may be attached. In the alternative prior artconfiguration, the device comprises an anchor member, which may take theform of an arrowhead or similar conical configuration, which furtherincludes a shaft or attachment member extending therefrom, the latterbeing formed to have one or more apertures to which the sutures or othermaterial may be attached.

[0005] With respect to the surgical installation of such devices,bone-screw mechanisms must necessarily be screwed in position, typicallyby a battery-powered screw driver, at a target site upon a particularbone. Anchor devices of the other aforementioned variety typically mustbe “shot” into position at a particular site within a bone, typicallyvia a spring-loaded delivery mechanism. Exemplary of such bone-anchorinsertion devices include the In-Fast and In-Tac bone screw and boneanchor fixation devices previously produced by Influence, Inc. of SanFrancisco, Calif., now a division of American Medical Systems, Inc.

[0006] Although such prior art anchor devices generally providesufficient support to the various sutures and grafts affixed thereto,such fixation devices suffer from numerous drawbacks. In this regard, itis difficult for the surgeon to accurately deploy the insertion devicesuch that the anchor is correctly inserted at the target site. Moreover,substantial difficulty arises in removing and adjusting such devices.This latter task is especially problematic with respect to bone-screwdevices insofar as the surgeon attempting to remove the same must takegreat care to insure that the removal device, also typically comprisinga battery-powered screw driver, properly unscrews the anchor member fromits seated position. Other prior art anchor devices are even furtherproblematic insofar as the same are often irretrievable once deployed,especially in situations where the same are deployed too deeply into thebone mass.

[0007] Additional problems exist with prior art bone fixation systemsinsofar as the same have a tendency to become dislodged over time fromtheir seated position. In this regard, due to the repetitive applicationof stress or strain upon the bone anchor via the suture or soft tissueattached thereto, such anchors can eventually become loose and slip outof engagement from their fixed position. This tendency is especiallylikely to the extent repetitive and persistent application of strain andstress is applied in one specific direction or orientation. In thisregard, many fixation techniques are susceptible to failure withmisplacement or pull-out of anchors and eventual dislodgement of thestructure/graft supported thereby with coughing, vomiting or otherviolent activity. Moreover, even to the extent such bone anchoringsystems remain securely in position, recent study tends to indicate thatsuch bone fixation devices may actually have a tendency to cut thesutures sought to be held thereby.

[0008] Separate and apart from the drawbacks associated with the use ofprior art bone anchoring systems is the fact that often times anchorsystems provide far more structural support than is necessary for agiven surgical application. In this respect, numerous surgicalprocedures requiring the fixation of sutures and/or soft tissue requireonly a minimal degree of tension. Exemplary of, and perhaps mostwell-known of such procedures include pelvic prolapse surgery, alsoknown as colpopexy, colporrhaphy or vaginofixation, and transvaginalsling surgery, the latter of which is performed to treat incontinence.The former procedures typically involve the anchoring of all or aportion of the prolapsed vagina to adjacent or nearby structures such asthe sacrum whereas sling surgery essentially involves the formation of agraft positioned beneath the urethra with the opposed ends thereof beingsecured to either one of the abdominal fascia, Cooper's ligament orpubic bone. While such slings typically require little to no tensiononce fixed into position, due to the lack of alternative means foraffixing the opposed ends of such sling into position relative to thepubic bone, such prior art bone anchor devices must necessarily bedeployed. As a result, time spent in surgery is increased and thepatient undergoing such procedures in subjected to a far more traumaticexperience and has a possibly greater susceptibility of becominginfected by virtue of the deployment of such anchor devices than wouldotherwise occur to the extent alternative, less traumatic affixationdevices could be deployed. Along these lines, a substantial risk existssimply by utilizing a retropubic route to gain access to the surgicalsite where such sling is affixed into position. In this regard,accessing such surgical site via a retropubic route can increase therisk of bleeding and/or intestinal injury due to the proximity of bloodvessels existing within and above the pubocervical fascia and theintestines.

[0009] Accordingly, there is a need in the art for systems, devices andmethods for affixing sutures, grafts, soft tissues, synthetic materials,and the like to bone and soft tissue that are easier to deploy,manipulate and can remain more firmly seated into position than priorart devices, especially in the performance of suburethral sling,colporrhaphy and colpopexy procedures. There is additionally a need forsuch devices that can be utilized in a wide variety of surgicalapplications and may be further customized for use for particularapplications such that an optimal degree of support or leverage can beprovided thereby. There is further a need in the art for affixationsystems, devices and methods that can provide for means for affixingsutures, grafts, soft tissues, synthetic materials, and the like intoposition that are less traumatic, easier to deploy and adjust, and maybe readily removed and repositioned at a particular site than prior artsystems and devices.

BRIEF SUMMARY OF THE INVENTION

[0010] The present invention specifically addresses and alleviates theabove-identified deficiencies in the art. In this regard, the presentinvention is directed to novel devices, systems and methods for theattachment of sutures, grafts and other types of tissues and materialsto bone, periosteum, ligaments, fascia and other soft tissue as may bewarranted in a given surgical procedure. The devices of type presentinvention are particularly well suited for the secure placement of oneor both of the opposed ends of a suburethral sling for use insuburethral sling surgery, but are by no means limited to suchparticular application.

[0011] In a first preferred embodiment, the invention comprises animplant implantable within bone, ligaments, fascia and other soft tissueat a desired location. The implant comprises a piton portion designed topierce into and engage with the bone, or tissue, and a support structurecoupled therewith, the latter of which may take the form of a post, hookor eyelet to which the suture, graft, or tissue may be attached. Theimplants of the present invention may further include a handle memberformed thereon to facilitate the insertion and removal of the implantfrom its fixed or seated position within the bone/tissue.

[0012] The piton portion of the implant is specifically designed tobecome more firmly embedded within the bone or other tissue whenpressure is applied to the support structure in a first direction, butmay be dislodged or removed when the implant is pulled in an opposed orsecond direction. The piton member may be further selectively sized andadapted for use in a particular application, and may be particularlydesigned to penetrate up to certain depths and/or be capable ofsupporting a specific quantity of mass or weight. In this regard, theimplants may be designed to have two or more piton members, that eachrespectively provide means for securely attaching such implant to adesired side. Such implants may be further configured such that multipleimplants may be deployed upon a length of a suture, such that the suturemay be selectively pulled and anchored into position along a desiredpathway. In this respect, the piton members may be formed such that thesame are operative to facilitate movement through tissue in onedirection, yet perform an anchoring function in an opposite direction.

[0013] Such embodiment further advantageously allows for post-operativeadjustment whereby the suture with piton members attached thereto can beselectively pulled along the desired pathway to the extent necessary toadjust the suture position and/or introduce a greater degree of tensionthereto. Along these lines, such embodiment has the additional advantageof being completely removable from the patient's body by virtue of itsability to selectively move through and out of tissue.

[0014] In a second preferred embodiment, the invention comprises a discanchoring system that is operative to serve as a platform to whichsutures, graphs and the like may be secured or, alternatively, serve asa support for forming a suture “bridge”. According to one preferredversion, the affixation device comprises a disc or anchor plate which ispositionable upon a layer to tissue, such as a layer of muscle, fascia,or ligament, and in particular, the rectus fascia layer. The anchoringplate is preferably formed to be generally circular in nature andcomprised of an inner plate member encased within an annular outer platemember. The inner and outer plate members are further preferably formedsuch that at least one, and preferably two, diametrically opposedapertures are formed respectively therein for receiving suture linesinsertable therethrough. The inner plate and outer annular member areformed relative one another such that the inner plate is rotationalrelative the outer annular ring and operative to transition between afirst open configuration, wherein said apertures formed upon therespective plates are open to receive suture lines therethrough and asecond closed configuration, wherein rotation of the inner platerelative to the annular ring causes the apertures to close and lock,(i.e., crimp) any suture line extending therethrough to become rigidlysecured in position. To the extent desired, those portions of thesutures extending through the anchor plate may be affixed to one anotherto thus form a bridge or adjoining suture link.

[0015] In an alternative configuration, the disc anchoring systemcomprises a disc or anchor plate which is likewise positionable upon alayer of tissue (e.g., muscle, fascia, or ligament) that includes atleast one, and preferably two to four, channels for receiving suturelines insertable therethrough. The channel or channels are configuredsuch that the same are crimpable such that when the suture line or linesare ideally positioned therein or impart the necessary degree of supportto an object (i.e., sling, graft, etc.), the crimping of such channel orchannels affixes such length of suture or sutures into position. Toachieve that end, it is contemplated that any of a variety ofconventional crimping devices may be deployed to impart the necessarycrimp in the channel or channels. As per the aforementioned embodiment,to the extent multiple suture lines extend through such plate, the samemay be tied, linked, crimped or otherwise joined to one another to forma suture bridge.

[0016] The disc anchoring system may further take the form of a systemwhereby a suture, having a plurality of protuberances formed therealong,is engageable with an anchor plate, the latter having an aperture formedtherein for receiving the suture line. As respective ones of theprotuberances extend through and rest against the anchor plate, thesuture line may thus be maintained in a fixed position relative adesired target site. Such embodiment advantageously provides forpost-operative adjustment should it become necessary to reposition thesuture or increase the tension within the suture line secured by thedisc anchoring system.

[0017] In all embodiments, the disc anchoring systems are particularlywell suited for the use in pubovaginal sling surgery where it isnecessary to secure a sling such that the sling extends a desireddistance from the urethra or exerts a desired degree of supportivepressure thereto, which thus necessitates that such sling be selectivelysecured into position via the suture extending through the anchor plate.It will be recognized, however, that such disc anchoring systems may beutilized for a wide variety of medical applications and further, may beformed to be permanently affixed into position or formed from abio-absorbable material to the extent such anchoring systems need onlyremain resident for a limited duration. Still further, it iscontemplated that each of the aforementioned disc anchoring system mayincorporate a load-bearing object, such as a washer, mesh or other likestructure, as part of or in conjunction with the disc anchoring systemto facilitate the distribution of stress and strain imparted thereto. Aswith the disc system, such load distributing apparatus may be formed tobe permanently secured into position or formed from an absorbablematerial.

[0018] In a third preferred embodiment, the invention comprises anaffixation device designed to secure sutures, grafts, tissues, syntheticmaterials, and the like to periosteum (i.e., the thick fibrous membranecovering the surface of bones) and other soft tissue. According to apreferred embodiment, the affixation device includes a backing or basemember having at least one, and preferably a multiplicity of hookmembers that are sized and adapted to hook into and ensnare with theperiosteum or tissue. The hook members may be specifically designed tobecome partially embedded within the periosteum tissue, to thus providerelatively loose connection that is easier to remove, or adjust, and maybe designed to penetrate deeper within the periosteum tissue to thusprovide a more secure method of attachment. An attachment member formedupon the base member is further provided to which may be attached asuture or a portion of a graft.

[0019] In an alternative preferred embodiment, the invention comprisesan implantable tack consisting of a hub member having at least one, andpreferably two or more hook members formed thereon, the latter beingdesigned to extend through the graft or tissue and become ensnared withand embedded in the periosteum such that the graft or tissue becomesinterposed between and affixed into position relative the tack andperiosteum. The affixation devices according to such embodiments arespecifically designed for selective attachment and detachment, and arefurther designed to provide more atraumatic means for the attachment ofthe suture or graft to a target location via the periosteum and softtissue. Such a fixation device, however, may be adapted such that thesame are designed to pierce into and become embedded with the bone, asper the other aforementioned embodiments.

[0020] In yet another embodiment of the present invention, there isprovided a novel surgical staple that is also designed to secure a graftor other types of tissues and materials to the bone, periosteum, orother soft tissue at a specific site or location. The staples of thepresent invention are preferably formed from plastically deformablematerials having opposed ends that are designed to penetrate through thegraft/tissue and hook into the bone, periosteum or soft tissue at aselected site of fixation. Once secured in position, the staples areoperative to assume an expanded configuration such that the hooks formedthereby become more firmly embedded within the bone/tissue at the targetsite of fixation to thus further secure attachment of the graft thereto.Preferably, such staples may be fabricated from a shape-memory material,such as nitinol, which thus enables the staple to assume the compressedconfiguration when at room temperature, but transition to the operative,expanded configuration when warmed to body temperature, as will occurwhen the device is deployed. Such materials further enable the staplesof the present invention to be removed, as may be necessary, during agiven procedure or later procedures. Conversely, such staples may beformed from material that enable the same to compress or contract oncesecured into position to thus provide for a more secure means ofattachment.

[0021] The present invention further comprises novel surgical approachesfor the secure placement of a transvaginal sling during transvaginalsling surgery. More particularly, such surgical procedure involvessecuring such sling into position, namely, beneath the urethra, with theopposed ends thereof being secured to the posterior portion of the pubicbone, whether it be either the pubic bone itself or the periosteumsurrounding the same, in the retropubic space. The opposed ends of thesling may be attached to either the periosteum over the pubic bone or tothe pubic bone itself using the novel affixation devices of the presentinvention. Advantageously, such surgical procedure eliminated the needsto form an abdominal incision, which typically must be made utilizingconventional surgical procedures. The novel affixation method of thepresent invention during such surgery further provides for the ingrowthof the opposed ends of the graft to a target site near or on the pubicbone or the periosteum thereabout that eliminates any intervening pelvicfascia that would otherwise become interposed between the anchor andopposed ends of the sling sought to be secured into position.

[0022] As an alternative to the aforementioned approaches, the presentinvention further comprises novel systems and surgical techniques thatcan deploy anchoring systems for the placement of radio opaque markers,such as the TINED lead system of radio opaque markers produced byMedtronic, Inc., and pelvic floor reconstruction for support of pelvicorgans, such as through the use of slings affixed thereto, that arefixed into position via trans-obturator placement, as opposed toconventional retropubic surgical placement. Such surgical techniques,devices and systems utilized therewith are positioned utilizing a singlepercutaneous incision made in the vaginal epithelium which enables asling to be anchored into position in a target tissue, such as rectusand/or pubocervical fascia, via sling placement toward or through theobturator foramen. To achieve that end, there is preferably provided adeployment system operative to selectively deploy and securely placeinto position a self-anchoring sling comprised of an elongate slinghaving opposed ends. Formed on each opposed end of such sling arededicated anchor mechanisms that are each operative to penetrate intoand become embedded within a target site of soft tissue, such as theobturator membrane situated within or around the obturator foramen.

[0023] Each respective anchor mechanism is operatively configured suchthat each anchor mechanism is advanceable in a first direction throughthe soft tissue at the target site but selectively adjustable to resistmovement in an opposed direction, (i.e., such anchor mechanisms areconfigured such that the opposed ends of the sling are capable of beingadvanced in opposed directions but resisting or preventing contractionor other similar type of motion drawing the ends towards one another).To facilitate such movement, it is contemplated that the anchormechanisms may take the form of screws, arrowheads, prongs, and inparticular generally Y-shaped or chevron shaped prongs, or any otherstructure that is capable of being advanced in one direction yet resistsor is biased against movement in an opposed direction. In furtherrefinements such anchor mechanisms may further be selectively configuredto penetrate to a desired depth within a tissue mass, as well as may beselectively configured to assume a first compressed or deploymentconfiguration such that the same will be operative to be positionedwithin a specific target site, and a second operative configurationwhereby the anchor mechanism expands or otherwise assumes a lockingconfiguration that enables the anchor to become affixed into position.In this regard, it is contemplated that the anchor mechanism may beformed to have an outwardly expanding spring bias such that oncereleased from a confined position automatically expands or anchors in anautomatic fashion.

[0024] With respect to the deployment of such slings, it is contemplatedthat the same will be deployed through a manually operable deploymentmechanism. Preferably, such deployment mechanism will include a handlehaving a deployment member extending distally therefrom. With respect tothe latter, the deployment member will preferably be configured forinsertion through and under the vaginal wall to thus enable the slingswith anchor mechanisms formed thereon to be deployed via atrans-obturator or other route. To facilitate that end, it iscontemplated that the deployment member may be provided with a sharpeneddistal end capable of forming an incision within the vagina andthereafter be extensable under the vaginal wall to thus deploy theslings of the aforementioned variety within or near the obturatorforamen. In use, the sling having the anchoring mechanisms formed uponthe opposed ends thereof will be coupled to or mounted upon thedeployment member such that a respective one of the anchor mechanismscan be positioned by the deployment member at a specified site withinthe target tissue (e.g., the pubocervical fascia or within the obturatorforamen). In this regard, it is contemplated that the deployment membermay be configured such that the anchor mechanisms will be deployed in asequential manner such that a first anchor is deployed in one targetsite and the other opposed anchor member deployed at a second site suchthat the sling disposed intermediate the anchor members can beselectively positioned to provide an optimal degree of support to theurethra. In order to manipulate such device, it is contemplated that thedeployment system will include an actuation member that enables thesurgeon to manually direct the advancement of the anchor mechanismcoupled with or mounted upon the deployment member of the mechanism tothus enable the self-anchoring sling to be controllably fixed intoposition. To facilitate such placement, it is contemplated that thedeployment member may be selectively curved or shaped to gain accessmore readily within a particular anatomical site, such as the obturatorforamen.

[0025] Related to the foregoing techniques and further encompassedwithin the scope of the present invention are surgical techniques,slings and anchoring devices for performing vaginal reconstructionsurgery, such as vaginal prolapse surgery. According to such technique,the prolapsed vagina in inverted such that the same attains its properanatomical orientation and, as per the aforementioned techniqueregarding the deployment of anchoring mechanisms within the obturatorforamen, at least one, and preferably an opposed pair of anchoringmechanisms are deployed through the vaginal wall and into the obturatorforamen, thus causing the vaginal wall to remain anchored in its properanatomic orientation. To that end, it is contemplated that the anchoringmechanisms are operative to penetrate into and become embedded within atarget site of soft tissue within or around the obturator foramen in asecond platform or mesh portion which remains embedded or compressedagainst the vaginal wall to thus support and retain such structure intoposition. To facilitate that end, it is contemplated that such anchormembers will include a platform surface formed from mesh or other likematerial to thus provide sufficient surface area to support the vaginalwall into proper positioning.

[0026] It is therefore an object of the present invention to providesurgical implantation devices to facilitate the attachment of sutures,grafts, tissues and the like to bone, periosteum and soft tissue thatare easier to implant and remove than prior art devices, and are furthercapable of providing greater support or leverage to the structurescoupled therewith than prior art devices.

[0027] Another object of the present invention is to provide surgicalimplantation devices for the attachment of sutures, grafts, tissues andthe like to bone, periosteum and soft tissue that can be utilized in awide variety of surgical procedures, and in particular colpopexy,colporrhaphy, suburethral sling or other pelvic support surgery, andthat may be further designed to provide an optimal degree of support fora given quantity of mass or weight as may be necessary for a givensurgical procedure.

[0028] Another object of the present invention is to provide devices forthe affixation of sutures, grafts, tissues and the like to periosteumand soft tissue at a specific site or location that does not require anyanchoring mechanism to be inserted into the bone.

[0029] Another object of the present invention is to provide devices forthe attachment of sutures, grafts, tissues and the like to bone,periosteum and soft tissue at a specific location that are lesstraumatic than other prior art affixation devices.

[0030] Another object of the present invention is to provide devices forthe attachment of sutures, grafts, tissues and the like to boneperiosteum and soft tissue at a specific location that are easilyattachable to and detachable from a point of fixation than prior artdevices and re-attachable as may be necessary for a given procedure orfuture procedures.

[0031] Still further objects of the invention include methods anddevices for securing sutures, grafts, tissues and the like to bone,periosteum and soft tissue that are of simple construction, may beeasily and readily utilized for a variety of surgical procedures, may bereadily adapted for use in a wide variety of surgical procedures, andprovide an equal, if not greater degree of support or leverage thanprior art devices.

[0032] Another object of the present invention is to provide aself-anchoring sling that enables the sling to be securely affixed intoposition within a site of soft tissue such that the same resists sag orotherwise lessens its ability to provide support that can furtherpreferably be deployed via a trans-obturator route, and preferably via asystem and method that enables the same to be deployed via a singleaccess route, such as a single vaginal incision, to thus eliminate risksassociated with sling delivery via a retro-pubic route.

[0033] Another object of the present invention to provide a novelsurgical procedure for the formation and affixation of a suburethralsling whereby the opposed ends of the sling are secured near or at theposterior side of the pubic bone in the retropubic space with theopposed ends of the sling being secured to either the periosteum,Cooper's ligament, fascia or the pubic bone itself.

[0034] It is another object of the present invention to provide a novelsurgical procedure for performing vaginal prolapse surgery, as well asprovide devices for performing vaginofixation such that the vagina issurgically positioned according to its proper physiological orientationby anchoring the same in or around a target site of soft tissue,preferably situated at or near the obturator foramen.

BRIEF DESCRIPTION OF THE DRAWINGS

[0035] These, as well as other features of the present invention willbecome more apparent upon reference to the drawings wherein:

[0036]FIG. 1 is a frontal, cross-sectional view of the rectus fascia,pubic bone, urethra and vagina further depicting a sling memberpositioned about the urethra or in which the respective ones of opposedends of the sling are secured to the pubic bone.

[0037]FIG. 2 is a side cross-sectional view of the anatomical structuresdepicted in FIG. 1 and further depicting the fastening arrangement bywhich the sling is anchored to the posterior portion of the pubic bone.

[0038]FIG. 3 is a prior art surgical instrument utilized to secure theanchor member depicted in FIG. 2 to the posterior of the pubic bone.

[0039]FIG. 4 is a cross-sectional view of the pubic bone having a priorart anchor device secured thereto.

[0040]FIGS. 5a and 5 b are perspective views of prior art anchordevices.

[0041]FIGS. 6 and 6a are a perspective view of a surgical implantconstructed in accordance with a preferred embodiment of the presentinvention for use in attaching sutures, grafts, tissues and the like tobone, periosteum, and soft tissue, and a side view of the same beinginserted into bone.

[0042]FIG. 7a is a perspective view of a surgical implant constructed inaccordance with a second preferred embodiment of the present inventionfor use in attaching sutures, grafts, tissues and the like to bone,periosteum, and soft tissue. Such figure depicts the surgical implantassuming a pre-insertion configuration.

[0043]FIG. 7b is a perspective view of the surgical implant of FIG. 7awith the implant assuming an expanded, anchoring configuration.

[0044]FIG. 8 is a perspective view of a surgical implant constructed inaccordance with a third preferred embodiment of the present inventionfor use in attaching sutures, grafts, tissues and the like to bone,periosteum, and soft tissue.

[0045]FIG. 9 is a cross-sectional view of the pubic bone and periosteumthereof having an affixation device affixed with the latter, saidaffixation device being constructed in accordance with a fourthpreferred embodiment of the present invention useful for securingsutures, grafts, tissues and the like to bone, periosteum and softtissue.

[0046]FIG. 10 is a perspective view of the affixation device depicted inFIG. 9.

[0047]FIG. 11 is a cross-sectional view of the pubic bone and periosteumformed thereabout having an opposed end of a graft being secured theretowith an implantable tack, the latter being constructed in accordancewith a fifth preferred embodiment of the present invention.

[0048]FIG. 12 is a cross-sectional view of the pubic bone and periosteumformed thereabout showing the graft depicted in FIG. 11 being securedthereto via the implantable tack.

[0049]FIG. 13 is a frontal view of the graft depicted in FIGS. 11 and 12as secured to the periosteum via the implantable tack of the presentinvention.

[0050]FIG. 14 is a cross-sectional view further depicting an expandedview of the pubic bone with periosteum formed thereabout having anopposed end of the surgical sling affixed to the periosteum via asurgical staple, the latter being constructed in accordance with a sixthpreferred embodiment of the present invention, the staple assuming afirst insertion mode.

[0051]FIG. 15 is a side-view depicting the surgical staple depicted inFIG. 14 securing an opposed end of the sling to the periosteum, thestaple assuming a second, affixation configuration.

[0052]FIG. 16 is a cross-sectional view of a suture having a pluralityof affixation devices secured thereto, the latter constructed inaccordance with a preferred embodiment of the present invention, for usein securing the suture along a desired pathway through tissue.

[0053]FIG. 16a is a perspective side view of FIG. 16.

[0054]FIG. 17 is a frontal, partially cross-sectional view of a slingbeing secured beneath a urethra and selectively secured into position tolayers of muscle/rectus fascia via an anchoring plate fixation device asconstructed in accordance to a preferred embodiment of the presentinvention.

[0055]FIGS. 17a and 17 b are top views of the fixation device utilizedin FIG. 17, the fixation device being shown in a first operativeconfiguration in a second locking or closed configuration.

[0056]FIG. 18 is a perspective view of an anchoring system constructedin accordance with another preferred embodiment of the presentinvention.

[0057]FIG. 19 is a perspective view of an anchoring system constructedin accordance with another preferred embodiment of the presentinvention.

[0058]FIG. 19a is a partial cross-sectional view of the system depictedin FIG. 19 shown with a suture line extending through a channel definedthereby.

[0059]FIG. 19b is the cross-sectional view of FIG. 19a wherein thechannel of said anchoring system is shown in a crimped configuration,the crimp maintaining the suture disposed within the channel in fixedposition.

[0060]FIG. 19c is a cross-sectional view of the anchoring systemdepicted in FIG. 19 with one channel extending therethrough, saidchannel having two suture lines extended therethrough.

[0061]FIG. 20 is a perspective view of a sling deployment systemcomprised of a self-anchoring sling member comprised of an elongatesling having anchoring mechanisms formed on the opposed sides thereof, arespective one of the anchoring mechanisms being coupled with a manuallyoperable sling deployment mechanism constructed in accordance with apreferred embodiment of the present invention.

[0062]FIG. 20a is a perspective view of the sling member depicted inFIG. 20.

[0063]FIG. 20b is a perspective view of the sling deployment mechanismdepicted in FIG. 10.

[0064]FIG. 21 is a perspective illustration of the sling deploymentsystem and components thereof as depicted in FIGS. 20, 20a and 20 bwherein a respective anchor mechanism of the sling component is advancedinto an incision made in a vaginal wall.

[0065]FIG. 22 is a perspective view of the self-anchoring sling depictedin FIGS. 20, 20(a) and 21 as positioned within the obturator foramen andoperative to support the patient's urethra.

[0066]FIG. 22a is a perspective view of an embodiment anchoringmechanism as incorporated within the self-anchoring slings of thepresent invention as constructed in accordance with a preferredembodiment.

[0067]FIG. 22b is a perspective view of an embodiment anchoringmechanism as incorporated within the self-anchoring slings of thepresent invention as constructed in accordance with another preferredembodiment.

[0068]FIG. 22c is a screw-type anchor for use with the self-anchoringslings of the present invention as constructed in accordance with yet afurther preferred embodiment.

[0069]FIG. 23 is a frontal view of a prolapsed vagina and thepositioning of the obturator foramen relative thereto.

[0070]FIG. 24 depicts the vaginofixation of the prolapsed vagina in FIG.23 utilizing a fixation device constructed in accordance with apreferred embodiment of the present invention.

[0071]FIG. 25 is an enlarged perspective view of the fixation devicedepicted in FIG. 24.

[0072]FIG. 26 is a perspective view of the fixation device of FIG. 25 asconstructed in accordance with an alternative preferred embodiment ofthe present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0073] The detailed description as set forth below in connection withthe appended drawings is intended as a description of the presentlypreferred embodiments of the invention, and is not intended to representthe only form in which the present invention may be constructed orutilized. The description sets forth the functions and sequences ofsteps for constructing and operating the invention in connection withthe illustrated embodiments. It is understood, however, that the same orequivalent functions and sequences may be accomplished by differentembodiments and that they are also intended to be encompassed within thescope of this invention.

[0074] Referring now to the drawings, and particularly FIGS. 6-15. thereare shown various embodiments of the devices and systems of the presentinvention for securing sutures, grafts, tissues and synthetic materials,and the like to bone, periosteum and other soft tissue. As is well knownin the practice of medicine, a wide variety of surgical procedures oftennecessitate the use of anchoring devices for purposes of attachingsuture lines and grafts to bone. Exemplary of such anchoring devicesinclude those disclosed in U.S. Pat. Nos. 5,370,662 and 5,443,482, theteachings of which are expressly incorporated herein by reference asfrequently deployed in orthopedic, gynecologic, and urologic surgicalprocedures.

[0075] Among the more well-known surgical procedures incorporating theuse of such anchoring devices include transvaginal sling surgery. Asillustrated in FIGS. 1 and 2, such surgical procedure 10 involves theformation of a sling 12, which may comprise a harvested graft from adonor, or the patient's own tissue or an elongate strip of fabricatedsynthetic material or some combination thereof, that is introduced viaan opening made to the vaginal wall 14 selectively positioned beneaththe urethra 16. Once properly positioned, the sling 12 is secured intoposition. Unlike conventional transvaginal sling surgery, however, thesling 12 as depicted in FIGS. 1 and 2 is secured within the retropubicspace via an anchoring mechanism 20, more clearly depicted in FIG. 2. Aswill be appreciated by those skilled in the art, the method by which theopposed ends 12 a, 12 b of the sling 12 are secured, namely to theposterior side of the pubic bone 18, represents a novel approach insofaras such sling 12 is stitched into position in the retropubic space 22,as opposed to the suprapubic space which is conventionally utilized.Unlike alternative methods of performing suburethral sling procedures,such transvaginal sling surgical procedure advantageously dispenses withthe need to form an incision in the patient's lower abdomen 24 to thusenable the surgeon to gain access to the various anatomical structures,such as the abdominal fascia, pubic bone, or Cooper's ligament, to whichthe opposed ends of such sling are to be attached. As is well known,performing such abdominal incision increases operative time, increasesthe chances of infection, delays recovery time, and leaves undesirablescarring. Moreover, such sling procedure as depicted does not requirethat the sutures or opposed ends of the grafts be caused to penetratethrough the intervening pubocervical fascia 28, depicted in FIG. 1,present in the retropubic space 22 which, as will be appreciated bythose skilled in the art, prevents ingrowth of the opposed ends 12 a, 12b of the sling 12 sought to be secured in position.

[0076] As a result of the support imparted by the sling 12 to theurethra 16 during such times as the patient makes provocative gestures,as occurs during coughing, such sling 12 serves as support that preventsincontinence occurring during such provocative event. To insure that thesling 12 is positioned such that the same imparts an optimal degree ofsupport to the urethra 16, it is contemplated that a tension/pressuremonitor 26, as depicted in FIG. 1, may be utilized during theperformance of such surgical procedure. Such tension/pressure monitors26 may take any of a variety of forms such as those disclosed inApplicant's co-pending U.S. patent application Ser. No. 09/157,466, theteachings of which are expressly incorporated herein by reference.

[0077] In order to provide an anchoring mechanism necessary to securethe sling into position during transvaginal sling procedures, however,there must be deployed the aforementioned anchoring device 20. Asdepicted in FIG. 3, there is shown one such anchor deployment device 30,also known in the practice of medicine as a bone screw inserter, whichallows for bone-screw fixation. Perhaps the most well-known of suchdevices include the In-Fast and In-Tac bone screw and bone anchorfixation devices previously produced by Influence, Inc. of SanFrancisco, Calif. Such affixation devices are formed to have a generally“U” shape as shown that enables the distal-most end 32 thereof to beeasily inserted into the vagina and be correctly positioned on theposterior portion of the pubic bone. As will be appreciated by thoseskilled in the art, the distal-most end 32 of such fixation deploymentdevices 30 are designed to deploy an anchoring device by screwing orembedding the same into bone at a specific site.

[0078] As more clearly seen in FIG. 4, once deployed, the anchor devices34 are advanced through the periosteum 36 and become embedded into thebone. To provide means for affixing the suture lines or grafts thereto,there is typically formed on the anchor devices a post, hook or eyelet,as shown. Among the more well-known designs of such anchoring devicescurrently in use include those depicted in FIGS. 5a and 5 b. The firstsuch prior art device 34 depicted in FIG. 5a comprises a self-tappingbone screw 40, typically made of titanium, having an eyelet 42 formedthereon to which the sutures 44 or other material may be attached, asshown in FIG. 4. In the alternative prior art configuration 50 depictedin FIG. 5b, the anchor fixation device comprises an anchor portion 52,which may take the form of a conical member having a shaft or attachmentmember 54 extending therefrom, the latter being formed to have one ormore apertures 56 thereon to which sutures 58 or other material may beattached. Such devices are typically “shot” into position viaspring-loaded insertion devices, such as the In-Tac device discussedabove.

[0079] Although such prior art anchor devices, such as those depicted inFIGS. 5a and 5 b, generally provide sufficient support to the varioussutures and grafts affixed thereto, such fixation devices 34, 50 sufferfrom numerous drawbacks. With respect to the bone-screw fixation devices34, such devices are difficult to deploy and fix into position. In thisregard, such screw fixation devices 34 require the battery-operatedinserters 30 depicted in FIG. 3 that must necessarily drill the fixationdevice 34 into position. Removing such devices 34 is further problematicinsofar as the same must necessarily be unscrewed from their position,which as those skilled in the art will appreciate requires meticulousprecision.

[0080] Anchor devices 50 are also problematic insofar as the same arenot only difficult to deploy, typically via a spring-loaded gunmechanism, but are often times irretrievable once deployed. In thisregard, once such fixation device 50 is sufficiently embedded within thebone, the anchor portion 52 thereof cannot be reversibly extracted fromits embedded position within the bone. As such, to the extent suchanchoring devices 50 have been inappropriately deployed (e.g., deployedat a wrong location), there is little, if any, recourse to retrieve thesame. Additionally, such prior art bone screws 34 and anchors 50 havethe ability to become loosened and dislodged from their position once asufficient amount of pressure is applied thereto over time. Theprobability of becoming dislodged is further increased in thosesituations where a persistent strain is applied to such devices in asingle direction, as can occur when a suture or graft is hung upon theanchoring device. In such circumstances, surgical intervention isnecessary to not only retrieve the dislodged screw or anchor, but alsodeploy yet another of such devices as per the original surgicalprocedure.

[0081] Referring now to FIGS. 6-8, there are shown three embodiments 60,70, 80 of a surgical implant insertable into bone (as well asperiosteum, ligaments, and other soft tissue) which are useful inproviding means to secure sutures, grafts, tissues, synthetic materials,and the like to bone, as may be necessary for a given surgicalprocedure. Each of the embodiments depicted have the advantage of beingeasy to insert and remove, as well as provide an equal, if not greater,degree of support than prior art devices. Such novel implants furtherhave the ability to remain more firmly seated into position onceembedded in bone than such prior art devices.

[0082] Referring now to FIG. 6, there is shown a first embodiment 60 ofthe surgical implant. As illustrated, the implant 60 comprises a pitonmember 62 having an eyelet 64 formed thereon. The piton member 62preferably comprises an arcuate blade having proximal and distal ends,the latter being designed to be inserted into bone such that as the sameis advanced therein, there is defined a penetration pathway as indicatedby the latter “A”. Once inserted into the bone tissue at the target siteof fixation, the eyelet portion 64 of the implant will extend therefromas illustrated in FIG. 6a, which will thus provide the necessarystructure to which the sutures 66, grafts and the like may be attached.Although the embodiment shown depicts the use of an eyelet 64, it willbe recognized that other substitute support or attachment structures,such as posts, hooks and the like, including even sledged-on fixation ofthe suture or graft to the piton, may be utilized as may be necessaryfor a given application.

[0083] As will be appreciated by those skilled in the art, by insertingthe implant in the direction indicated by the letter “A”, it will beappreciated that to the extent a force is applied thereto, such as bysuture 60 or graft, via a vector having an orientation in the generaldirection of letter “B”, such force will necessarily cause the implantto wedge deeper and become more secure into position within the bone 38,and will thus cause the same to become more rigidly affixed intoposition unlike prior art devices which have a tendency to become looseand potentially dislodged with the application of greater amounts ofpressure and strain thereto.

[0084] Such implant further provides the advantage of being easy toremove. In this regard, due to its orientation within the bone, to theextent a pulling force is applied to the implant in the directionindicated by the letter “C”, such implant 60 will be caused to becomeeasily dislodged from its seated position to the extent it becomesnecessary to remove and/or reposition such implantable fixation device.Such ease of removal advantageously provides for a simpler, lesstraumatic procedure than those procedures involving prior art screw andanchor fixation devices.

[0085] Referring now to FIGS. 7a and 7 b, there is shown a secondembodiment 70 of a surgical implant designed to be embedded within boneor soft tissue to which may be attached sutures, grafts and the like.Such embodiment 50, similar to the embodiment 60 depicted in FIG. 6, isspecifically designed such that the same becomes more firmly seated intoposition within the bone to the extent a force is applied in a firstdirection, as indicated by the letter “D”. FIG. 7a depicts the surgicalimplant 70 assuming an insertion configuration which enables the same tobe implanted into bone at a target site selected by the surgeon. Suchimplant is provided with a piton member 72 having opposed flanges 72 a,72 b formed at the distal end thereof that are designed to spread apartin the directions “Y” and “Z” and become more deeply embedded within thebone to the extent a pressure is applied in a direction indicated by theletter “D”. Although the specific embodiment 70 shown depicts that theopposed flanges 72 a, 72 b flare outwardly, it is to be understood thatsuch flanges can be designed to curve inwardly. Moreover, although suchembodiment depicts two opposed flanges, it should be recognized thatsuch implant may have three or more flanges and that each respectiveflange may be designed to flare outwardly, as shown, or hook inwardly asmay be needed to a specific application.

[0086] Once firmly embedded within the bone, the eyelet portion 74 ofsuch implant may be utilized to attach sutures and the like. Ofadditional advantage, similar to the embodiment shown in FIG. 6, is thefact that such implant 70 may further be easily removed to the extent apulling or opposed force is applied in the direction indicated by theletter “E”. As such, to the extent it becomes necessary to remove orotherwise reposition such anchoring device, such anchoring device 70 maybe easily dislodged by application of such force. As will beappreciated, such design allows for easier and less traumatic removalthan prior art anchor and screw fixation devices.

[0087] Referring now to FIG. 8, there is shown a third embodiment 80 ofa surgical tissue implant useful as a fixation device to attach sutures,tissues, and grafts to bone, periosteum, and soft tissue. As per theother embodiments, such implant 80 includes a piton member 82,preferably formed as a sickle-shaped member, having an eyelet 84 formedon the proximal end thereof. Such implant 80 is designed to be embeddedinto the bone or other tissue in the direction indicated by the letter“F”. Once so secured into position, forces may be applied thereto, viaeyelet 84 in the direction indicate by the letter “G”, which will thuswork to further embed the piton member 82 into the bone via thepenetration pathway defined by the distal end of the piton member 82 sothat the implant becomes more secure therewithin. Likewise, to theextent it becomes necessary to remove such device 80, such device may beremoved by pulling or otherwise rearwardly retracting the implant in thedirection indicated by the letter “H” which, as discussed in the otherembodiments, provides for simpler and less traumatic procedure thanprior art methodology.

[0088] Although each of the aforementioned embodiments 60, 70, 80 areparticularly well-suited for insertion into bone, it should berecognized by those skilled in the art that the same may be utilized toaffix sutures, grafts, tissues, synthetic materials and the like toconnective tissue, and in particular, periosteum as per the furtherembodiments discussed more fully below. In this respect, each of theaforementioned embodiments 60, 70, 80 may be designed such that thepiton portion thereof pierces into and becomes embedded within suchtissue and remains firmly seated thereat so that the attachmentmechanism formed thereon can provide a service to which the sutures,grafts and the like may be attached.

[0089] As will further be appreciated, in each of the embodiments 60,70, 80 depicted in FIGS. 6-8, the orientation of each of the implants asthe same are embedded into the bone or tissue is crucial for thenecessary operation thereof. In this regard, it will be appreciated thatthe implant must be oriented such that the resultant tension or strainapplied thereto will cause the piton portion thereof to advance in thepenetration pathway defined thereby. Otherwise, to the extent tension isapplied in an opposed direction, such implant may be caused to dislodgefrom its seated position. As a consequence, it will be appreciated thatthe implants of the present invention must be selectively positioned,and that the surgeon must take great care in making certain that theultimate tension applied thereto is oriented to facilitate theattachment of the implant to the bone, as opposed to casing the same tobecome dislodged therefrom.

[0090] Referring now to drawings 16 and 16 a, there is shown anadditional surgical tissue implant 500 useful as a fixation mechanism toattach sutures, tissues, and grafts to soft tissue. In the embodimentdepicted, which is shown being deployed for use in securing a sling 502into position to provide support to a urethra 504, the implant 500comprises a plurality of dual-prong anchoring mechanisms 506 disposedlinearly about a suture-like cord or line 508, which enables such lineto advance through the tissue in one direction, but resists rearwardmovement in the opposite direction. As shown, the implants can beconfigured to have a generally V-orientation such that the suture 508bisects such implant and extends therethrough. As will be recognized,each respective implant will have an eyelet or other aperture throughwhich the suture, which may be a suture line or suture-like cord, may beextended. As will be further recognized, although depicted as having agenerally V-orientation, it will be appreciated that the anchoringmechanisms 506 may be arranged in a staggered configuration, extendalong only one side of the suture 508, or otherwise be radially disposedabout a length of the suture 508. Accordingly, it will be recognizedthat numerous other designs are contemplated that fall within the scopeof the present invention.

[0091] By linearly disposing the implants along the suture line, thesuture line may be advanced in a direction indicated by the letter “X”,but yet resist movement in the direction indicated by the letter “Y”.Advantageously, such arrangement enables the suture line 508 to bepulled into a desired position such that the sling 502 supported therebycan be caused to provide a selective degree of support to the urethra504 or otherwise maintain a desired distance therefrom. Furthermore, tothe extent the suture line 508 with implants 506 or the sling 502supported thereby are inappropriately positioned, it will be recognizedby those skilled in the art that, if necessary, the suture line 508 canbe cut and the suture with implants affixed thereto extracted completelyfrom the patient's body (and replaced, if necessary or desired). Suchdesign further advantageously permits for the adjustment of the sutureline and/or the sling supported thereby not only intro-operatively, butalso post-operatively insofar as the suture line 508 can be extendedfurther, for example, in the direction indicated by the letter “X”, asmay be desired to the extent it is necessary to add extra tension to thesuture line 508. Moreover, as discussed above, the suture line 508 canbe removed entirely from a patient's body. In such circumstances, asecond suture line 508 having such implants attached can be substitutedin its place.

[0092] An example of the application of such system is illustrated inthe side-perspective view of FIG. 16a. As illustrated, the sling 502 ispositioned about the urethra 504 and supported upwardly by thesuture-like cord 508 having the fixation devices 506 linearly disposedupon the length thereof. In this regard, each respective suture, cord,etc. 508 supporting each respective side of the sling 502 may beselectively caused to remain securely embedded at a desired positionwithin the rectus fascia 510 or other soft tissue. As will beappreciated by those skilled in the art, due to the ability of thesuture lines or suture-like cords 508 with the novel implant fixationdevices 506 affixed thereto, the surgeon can incrementally increase thepressure exerted by the sling 502 against the urethra 504 or thedistance by which the sling 502 extends from the urethra 504 merely byincrementally advancing the suture line/cord 508 through the rectusfascia 510. As will be appreciated, there has not heretofore beenavailable any mechanism available which provides a surgeon with theability to merely advance a suture through tissue and have the sameremain firmly secured into position. Rather, and as discussed more fullyin the background, surgeons have had to identify a target site to whichsuch sling can be anchored and thereafter tie the same into positionsuch that the sling maintains the desired degree of support or distancefrom the urethra. As is widely recognized, malposition of the sling hasbeen deemed the cause for creating a significant problem andsubstantially high morbidity for those patients having undergone slingsurgery.

[0093] In a similar, yet further advanced variation of the embodimentdepicted in FIGS. 16 and 16a, there is shown in FIGS. 20-22 c a system800 comprised of the combination of a deployment mechanism 804 andsurgical implant 802, the latter being configured as per tissue implant500 that enables a sling portion 806 to be secured into position via theuse of anchor mechanisms 808 a, 808 b, the latter of which are operativeto advance through tissue in one direction but resist rearward movementin an opposite direction. In this regard, and as more clearly depictedin FIG. 20a, implant 802 will preferably be comprised of an elongatesling portion 806, which as those skilled in the art will appreciate maytake any of a variety of natural tissues, synthetic material or somecombination thereof operative to become implanted within the body andsupport a specified anatomical structure. Affixed on the opposed ends ofthe sling 806 are dedicated anchor mechanisms 808 a, 808 b which areaffixed to the respective ends of the sling 806 via a coupling apparatus810, which may likewise comprise any of a variety of attachmentmechanisms known in the art.

[0094] Each respective anchor mechanism 808 a, 808 b may be configuredper a variety of embodiments, discussed more fully below, that canenable each mechanism to be advanced into a target site of tissue in onedirection yet resist movement when pulled in an opposed direction. Inthis regard, each respective anchor mechanism 808 a, 808 b, will bepreferably formed upon the opposed ends of the sling 806 such that theanchor mechanisms 808 a, 808 b can be advanced through a target site oftissue in dissimilar directions, such as opposed directions, to thusenable the sling 806 to stretch beneath and ultimately support thetarget anatomical structure as previously discussed above with referenceto FIGS. 1 and 16 (as well as FIG. 22 more fully below). To achieve thatend, anchor mechanisms 808 a, 808 b may be provided with generallyarrowhead-shaped members, V-shaped members, Y-shaped members, or anystructure well-known in the art that facilitates the ability of theanchor mechanisms 808 a, 808 b to cut through and become positioned orembedded within a target site of tissue such that the same can becomeresident or fixed in position. In this regard, it is contemplated thatthe anchor mechanisms 808 a, 808 b, may be provided with a texturedsurface or otherwise be provided with materials to facilitate theingrowth of tissue about the same to thus enable the anchor mechanismsto remain firmly seated into position once implanted into the body.Illustrative of such an embodiment would include the use of a meshmaterial cut such that the strands of the fabric of such mesh facilitatemovement when advanced in a first direction but resist rearward movementdue to the frayed, outwardly-flaring strands of the mesh that would beoriented to cause such loose ends to resist or become biased againstrearward movement.

[0095] To facilitate the ability of the implant 802 to be accurately andsecurely placed into position within the body, a deployment mechanism804, more clearly depicted in FIG. 20b, may be utilized. Although theimplant 802 may be surgically implanted into position utilizing avariety of well-known surgical techniques, it is believed thatdeployment mechanism 804 may be useful to more quickly, accurately andatraumatically position and securely affix such implant 802 intoposition. As illustrated, the mechanism 804 comprises a manuallyoperable handle 812 having a deployment member 818 extending distallytherefrom. An actuator mechanism 814 is disposed within the handle 812and includes an elongate shaft portion 816 disposed axially within thedeployment member 818 such that the distal-most end thereof 816 a iscaused to selectively protrude through a distal-most opening 818 a ofthe deployment member 818. The actuator 814, and more particularly theshaft 816 thereof may be selectively coupled to an anchor mechanism suchas 808 a depicted in FIG. 20 to thus direct and position the anchormechanism 808 a at a target site within the body. Such deployment member818 may be configured to have a variety of sizes and shapes, and may bespecifically configured for deployment of an implant 802 at a particulartarget site within the body. For use in deploying implants, such as 802,to provide suburethral support for the treatment of incontinence, it iscontemplated that the deployment member 818 will have a generallyarcuate shape and may further be preferably configured to deploy theimplant 802 within the obturator foramen of a patient via atrans-obturator route, discussed more fully below.

[0096] To facilitate the interconnection between the implant 802, andmore particularly an anchor mechanism 808 thereof, with the deploymentmechanism 804, it is contemplated that such anchor mechanism 808 may bepre-loaded in a cartridge, not shown, the latter being selectivelyinterconnectable with the deployment member 818. In such embodiment, itis contemplated that such cartridge will be operative to form a rigidcasing about the anchor mechanism 808 to thus enable the anchormechanism to be easily affixed into position on the deployment member818 and thereafter surgically guided into position such that once atarget site has been accessed, the anchor mechanism 808 can beselectively deployed from the cartridge. To help enable the cartridge toreach such desired target site, it is contemplated that such cartridgemay be provided with a cutting apparatus or sharpened cutting edge tothus enable the same to cut and advance through tissue. To that end, itwill be readily appreciated by those skilled in the art that manypossible designs and configurations will be readily apparent toeffectuate that end.

[0097] Referring now to FIG. 21, there is shown the use of the system800 to deploy the implant 802 via the deployment mechanism 804. In theprocedure illustrated, such implant 802 is being deployed through anincision 822 formed within the vaginal wall 820 to thus enable a urethra824 to ultimately become supported thereby. To that end, it iscontemplated that such deployment may take one of two forms. Accordingto a first embodiment, the anchor mechanisms 808 housed within thedeployment mechanism are compressed to assume a first deploymentconfiguration and, once released therefrom, assume an expandedconfiguration that enables the same to remain fixed in position.Alternatively, the anchor mechanisms may simply assume a single stateand deploy directly into tissue at a desired surgical site. As will beappreciated, however, other techniques will be readily apparent to thoseskilled in the art for use in deploying the anchor mechanisms of thepresent invention.

[0098] In this regard, the procedure depicted in FIG. 21 representsdeployment of a suburethral sling via a trans-obturator route. As iswell-known, most slings are currently delivered via a retropubic route,and although the implants 802 and deployment mechanisms 804 can readilybe adapted and utilized for such procedures, current methodologysuggests that implant or sling deployment made via a trans-obtruatorroute substantially minimizes well-known risks associated with bleedingand/or intestinal or bladder injury associated with surgical slingimplant procedures utilizing a retropubic route to gain access to thesurgical site. In this regard, current medical literature stronglysuggests that a trans-obturator route substantially avoids the bloodvessels existing within and above the pubocervical fascia, bladder andthe intestines. Moreover, securing slings into position according toconventional methodology utilizing retropubic access often times resultsin sling dislodgement or misplacement, especially so when conventionalsling anchoring fails due to the pull or dislodgement of anchors and/ormesh when the patient engages in a violent provocative event, such ascoughing, vomiting or some other violent activity.

[0099] As shown, the deployment mechanism 804 is selectively positionedsuch that an anchor mechanism 808 a of the sling is advanced into theincision 822 via distally-extending deployment member 818. The actuator814, and more particularly the shaft 816 extending therefrom, isoperative to advance the anchor member 808 a away from the distal end818 a of the member and through the soft tissue until the same becomeswithin a target site of tissue. To facilitate the ability of themechanism to gain access to the target site, it is contemplated that thedistal-most end 818 a of deployment member 818 may be provided with asharpened cutting surface to thus enable the same to be advanced throughtissue via single incision 822. In an alternative approach, thedistal-most end 818 a wil cooperate with anchor mechanism 808 a to thusenable the implant to be advanced into and positioned throughpercutaneous incision 822 made in the vaginal wall 820. Along theselines, it is contemplated that once an anchor mechanism 808 a issufficiently positioned, the second anchor mechanism 808 b will beaffixed to the distal-most end of the deployment member 818 of mechanism804 and likewise be secured into position by selectively advancing theanchor mechanism 808 b through the same incision but in an opposeddirection relative the first anchor mechanism 808 a, the latter havingbeen secured into position and thus operative to resist rearwardmovement.

[0100] As will be readily appreciated by those skilled in the art, bymerely advancing the anchor mechanisms 808 a, 808 b, in generallyopposed directions, the anchor mechanisms will thus be operative tostretch out the sling portion 806 such that the same can selectively andaccurately be positioned about a target anatomical structure. In thisrespect, it is contemplated that the sling portion 806 can be positionedsuch that the same maintains a specified degree of tension or support toan anatomical structure, such as the urethra 824 or some part of thevagina as in a colporrhaphy or colpopexy, or may otherwise be positionedsuch that the same maintains a desired spatial relationship andorientation relative an anatomical structure. Of additional advantage isthe fact that each respective opposed anchor mechanism 808 of theimplant 802 can be positioned within the body via a single incision orpoint of access, which thus eliminates the need for a second incision oraccess point to be formed in the body, as is known per conventionalsling placement which typically requires that separate access points orincisions be made for each fixation point, (i.e., the points at whichthe opposed ends of the sling are fixed into position within the body).

[0101] As a consequence, and shown more clearly in FIG. 22, the implant802 may be selectively positioned such that the sling 806 componentthereof properly supports the urethra 824 as is desired to achieve afavorable outcome. In the placement of the implant 802 as depicted,however, the same illustrates the fixation of the implant 802, and moreparticularly the sling 806 thereof, within the obturator foramen ofpelvis 830, as defined by the pubis 834 and ishium 832 regions thereof.In this regard, each respective anchor mechanism 808 a, 808 b becomesembedded within a target tissue site, such as the pubocervical fascia,toward or through the obturator foramen and ultimately positioned in thedesired locale relative the bladder 828 and, more particularly, urethra824 extending therefrom.

[0102] As discussed above, anchor mechanisms 808 a, 808 b willpreferably be formed or attached to the opposed ends of the sling 806 tothus enable the opposed ends to be stretched out and positioned in thedesired manner. To achieve that end, it is important that the anchormechanisms 808 a, 808 b be configured to thus enable the same the beeasily advanced into position, to thus achieve the desired goal of fast,accurate and atraumatic placement, but at the same time provide thenecessary degree of anchoring support to thus define a secured point offixation from which the sling 806 can extend and ultimately impart thedesired degree of support. FIGS. 22a-22 c depict various embodiments ofthe anchor mechanism 808 that are contemplated to achieve thoseobjectives.

[0103] Referring now to FIG. 22a, there is shown an enlarged view of ananchor mechanism 808 similar to that depicted in FIG. 22. Asillustrated, the anchor mechanism comprises a plurality of anchor bodies840 each having opposed, outwardly extending anchor members or arms 842which thus define a generally Y-shaped body. Each respective anchormechanism 840 is disposed upon elongate cord 844, which may take theform of a suture or other implantable material well-known to thoseskilled in the art. To facilitate the ability to manipulate anchormechanism 808, elongate cord 844 may be formed to have a desiredstiffness, and may be formed as a cable having reinforced materialtherein operative to provide some structural rigidity as may be desiredin some applications.

[0104]FIG. 22b represents a similar embodiment whereby a plurality ofgenerally chevron-shaped anchor members 850 are disposed upon the lengthof an elongate cord 854. Each respective chevron-shaped member 850 isprovided with outwardly-extending members or arms 852 that provide ameans to anchor the same into tissue. Both the embodiments depicted inFIGS. 22a and 22 b, similar to those discussed above in relation to theembodiment depicted in FIGS. 16 and 16a, essentially comprise aplurality of dual-pronged anchor mechanisms disposed linearly about acord-like suture of various malleability to thus enable the same toadvance through tissue in one direction, either by pushing or pulling,but resist rearward movement in an opposite direction. In this respect,the generally Y-shaped and generally chevron-shaped embodiments depictedin FIGS. 22a and 22 b are similar to the generally V-oriented embodimentdepicted in FIGS. 16 and 16a to thus enable a plurality of anchoringmembers to be disposed upon a length of cord, suture and the like, to belinearly disposed there along. It will be recognized, however, thatnumerous other designs are contemplated that fall within the scope ofthe present invention. As discussed above, such anchor mechanism maycomprise selectively oriented segments of mesh material that areselectively oriented such that the loose or frayed fiber ends of themesh extend in a rearward configuration to thus resist rearwardmovement.

[0105] Referring now to FIG. 22c, there is shown a similar typeembodiment whereby the anchor mechanism 808 is defined by a screwmechanism 862, having a distal-most end 860 operative to advance intotissue along a central axis 864, the latter of which may be a cord orcable having a requisite stiffness. Alternatively, screw mechanism 862and central axis 864 may comprise a firm yet malleable material suitablefor implantation within the body. In such embodiment, it is contemplatedthat the screw-anchor mechanism 862 can be advanced into a target siteof tissue by either blunt advancement or rotational advancement, thelatter being facilitated by use of a deployment system 804 whereby thedeployment member 818 is operative to selectively position the samewithin a tissue mass.

[0106] As will be appreciated, alternative anchoring mechanisms arecontemplated and will be readily known to those skilled in the art.Along these lines, it is contemplated that the anchor mechanisms may beformed to be operatively transitional between a first compressed statewhereby one or more of the anchor members, and more particularly theoutwardly extending prongs thereof as depicted in FIGS. 22a, 22 b areadvanced into position within a target site of soft tissue and a secondoperative configuration whereby the anchor members and/or prongs thereofexpand to become fixed into position at the appropriate target site ofsoft tissue.

[0107] Although not shown, in order to achieve such selective placementof the anchoring mechanisms capable of operatively transitioning betweensuch first and second configurations, it is contemplated that suchanchor mechanisms may be selectively positioned via the use ofconventional deployment techniques and devices, such as catheters,needles, and/or guide wires. Exemplary of the latter, as utilized toposition such operatively transitional anchor mechanisms for use insling surgery, would be accomplished via the introduction of the guidewire through and then under the vaginal wall and then into the tissueadjacent to the vagina. Once properly positioned, an expansion is theneffectuated along the guide wire within the vaginal, via the use ofconventional coaxial or balloon systems or other well-known spreadingdevices that, following deployment, are thereafter removed. As per theprocedures discussed above, it is understood that once a first anchormechanism is deployed, a similar procedure must necessarily be followedto deploy the second respective anchor mechanism such that the slingdisposed therebetween is operatively positioned to impart the desiredsupport or positioning at a specified anatomical site.

[0108] Another example for use in deploying such operativelytransitional anchor mechanisms would include the use of an elongatesheath that is focused as a portion of the deployment member 818 isoperative to retain a multiplicity of anchor mechanisms, and inparticular a plurality of anchor bodies, such as 840 depicted in FIG. 2,within an elongate lumen thereof. It is contemplated that such sheathwill have a sharpened distal end to thus enable the same with anchorbodies retained therein to be selectively positioned such that theprongs or other attachment elements thereof do not cut, engage with orotherwise become prematurely deployed. Along these lines, it iscontemplated that such sheath deployment member would ideally beutilized to selectively position a multiplicity of anchor memberspositioned along a suture line or other cord-like structure, and mayfurther include mechanisms to facilitate the deployment of such anchormechanisms to either extend from or be withdrawn within the lumen ofsuch sheath. It is likewise contemplated that such sheath can be used todeploy a plurality of linearly-arranged radio opaque markers, such asthe TINED lead system of radio opaque markers produced by Medtronics,Inc. which have a configuration similar to that of the anchor bodiesdepicted in FIG. 22A. In use, it is contemplated that such sheath may beprovided with an elongate slot formed along a portion the length thereofthat enables the cord-like structure having one or more anchormechanisms formed thereon to be pulled or pushed into the sheath as wellas allow the sheath to be removed following the placement of the anchormechanism deployed thereby.

[0109] Referring now to FIG. 17, there is shown yet another embodimentof a device 600 for attaching sutures, grafts, tissues and the like intoposition in the human body. As illustrated, such embodiment comprises ananchoring disc or plate 602 which may be secured to or rest upon ananatomical structure, and more particularly a layer of muscle 604 orrectus fascia 606 as shown. As illustrated, which again is in thecontext of securing a sling 502 into position such that the urethra 504is supported thereby, suture lines or suture-like cords 508 on eachopposed end of the sling 502 are secured by dedicated anchoring plates602, the latter being supported by a layer of muscle and/or layer ofrectus fascia. As shown, the anchoring plates 602 are operative tosecure the suture lines 508 into position such that the same are allowedto selectively advance therethrough and remain secured in positionthereby without requiring that the sutures 508 be ties (i.e., at thefascia level 606).

[0110] To achieve that objective, there is shown in FIGS. 17a and 17 bthe mechanism by which the anchoring plate 602 is operative to securethe suture lines 508 thereto. As shown in 17 a, the anchoring plate 602comprises the combination of a first inner plate member 610 having atleast one, and preferably two diametrically opposed apertures 612 formedtherein. Encased about the first plate member 610 is a second annularplate member 614 which also includes at least one, and preferably two,apertures 616 formed therein, such apertures 616 being selectivelyalignable with the apertures 612 formed upon the first inner plate 610.The first inner plate member 610 is rotationally mounted within theouter anchoring plate member 614, such that the same is operative totransition between a first open configuration, wherein the apertures 612of the first inner plate 610 are alignable with those formed on theouter annular plate 614, and a second closed configuration, as shown inFIG. 17b, wherein the apertures formed on the inner and outer plates612, 615, respectively, are not aligned with one another, such that aclosure is formed.

[0111] In use, the anchoring plate 602 may be secured into position, viaprongs or some other type of anchoring mechanism (not shown) to adesired site. Alternatively, it will be appreciated that such anchoringplate 602 may only need be placed on the rectus fascia and, as discussedmore fully below, due to the downward force exerted upon the anchoringplate 602 via the sutures held thereby, such anchoring plate will becaused to remain resident at the desired deployment site. Oncepositioned, the inner and outer plate members 610, 614 are maintained inthe first operative configuration such that the apertures 612, 616,respectively formed thereon form the opening or openings through suchanchoring plate 602. The suture lines 508 may then be extended throughapertures defined by the first and second plate members such that thesling 502 held thereby is maintained in a desired orientation orprovides a desired degree of support to the urethra 504. Once sopositioned, the inner and outer plate members 610, 614 are rotatedrelative one another such that second closed configuration ismaintained, which thus serves to secure the suture lines 508 intoposition. To facilitate that end, a knob 618 or other turning mechanismformed upon the inner plate may be provided to facilitate theinsertionability to secure the suture lines 508 into position. Asdiscussed above, such design advantageously dispenses with the need totie down the suture lines or cords at the fascia level. To the extentdesired, such anchoring system further enables the suture lines, andmore particularly the suture lines extending through the anchor plate,to be secured to one another to thus form a suture “bridge”. As shown inphantom, each respective suture line extending through the anchor platecan be linked to one another as shown. To achieve that end, it will beappreciated that such suture lines may be either tied, fused, crimped,linked or joined to one another via any of a wide variety of methods anddevices well known to those skilled in the art.

[0112] Referring now to FIG. 18, there is shown a further refinement ofthe system utilized to secure a suture line at a desired location suchthat a sling, graft or other object supported thereby is maintained at adesired location. As illustrated, such system 640 comprises thecombination of a suture-like cord 642 having a plurality ofprotuberances 644 formed therealong and an anchoring plate 646. Thesuture-like cord 642 with protuberances 644 is formed such that the sameis extensible through tissue. As will be appreciated by those skilled inthe art, attached to an opposed end of such suture-like cord 642 withprotuberances 644 is a graft, sling 502 or some other object to be heldthereby. The suture-like cord 642 is extensible through the anchoringplate 646, the latter being secured at a desired target site, which mayinclude a bone, periosteum, soft tissue, or a layer of rectus fascia 606as shown. The suture 642 is extensible through such anchoring plates 646such that respective ones of the protuberances 644 engage with a lockingaperture 648 formed on such plate 646. As illustrated, each respectiveprotuberance 644 can be pulled through such aperture 648 and thereaftercaused to lock the suture 642 into position. As will be appreciated, asthe sutures 642 pull through the anchoring plate 646, the suture line642 will become progressively shorter and thus raise the object (i.e.,sling 502) held thereby to the desired location. Advantageously, suchsystem accommodated movement in both directions, and by pulling thesuture in the rearward direction can cause the suture to experience anincrease in slack, which thus consequently can lower or lessen thetension in the object supported thereby. As per the embodiment depictedin FIG. 17, these suture-like cords with protuberances, to the extentmultiple cords are utilized, may be linked to one another to thus form asuture bridge, as may be desired for certain applications.

[0113] Referring now to FIGS. 19-19 c, and initially to FIG. 19, thereis shown an additional embodiment 700 of an anchoring system forsecuring a suture-like cord or line 508 at a desired location. As perthe embodiments depicted in FIGS. 17 and 18, the embodiment shownincludes an anchor plate 702 having at least one, and preferably two tofour, channels 704 extending therethrough for receiving suture-likecords 508. As per the aforementioned embodiments, the anchor plate 702may likewise be secured into position with a fastener mechanism or,alternatively, merely be positioned at a desired site upon fascia orsoft tissue with the ultimate tension imparted thereto by the sutures508 held thereby causing the same to remain resident at such site. As tothe embodiment shown, the anchoring plate 702, once positioned, isoperative to receive the suture line or lines 508 through the channels704 defined thereby. As more clearly illustrated in the cross-sectionalview of FIG. 19a, the suture-like cord 508 can be pulled upwardly ordownwardly until the same attains the desired position and/or impartsthe desired tension to an object held thereby. Once such proper positionand/or tension is attained, the channel 704 within which the suture-likecord 508 is disposed may be crimped, as depicted in FIG. 19b, such thatthe suture line 508 is compressively held thereby. As will beappreciated by those skilled in the art, the channel 704 defined by theanchor plate 702 will be formed from a suitable deformable materialwell-known to those skilled in the art which can not only be easilycrimped, but once so crimped, will impart the necessary compressiveforce to hold the suture 508 in position. It will likewise be recognizedthat the crimp made to the channel 704 may be formed by any of a varietyof surgical crimping mechanisms well-known and commercially available.

[0114] In an alternative configuration depicted in FIG. 19c, the anchorplate 710 is designed such that the same only has one channel 712 formedtherethrough through which one or more suture-like cords 508 may bereceived. As may be desired for certain procedures, particularly whereit is advantageous to simplify such procedures, the channel 712 definedin the anchor plate 710 will preferably be centrally disposed upon theanchor plate such that the same is adapted to receive multiplesuture-like cords therethrough (e.g., four (4) suture lines toaccommodate two (2) opposed ends of a sling). Once the cord or cords 508have been received therethrough and optimally positioned, the channel712 may be crimped such that the cords are compressively held asdesired. Any length of the sutures extending therethrough may be linkedor connected to one another to thus form a suture bridge, which is againin phantom in FIG. 19.

[0115] As will be recognized by those skilled in the art, by providingsuch a simplistic, atraumatic mechanism for securing sutures, grafts andthe like into position substantially reduces suture erosion, greatlyminimizes operative time, patient recovery time and further minimizesthe risk of infection by minimizing the degree of invasiveness typicallyassociated with securing slings and the like into an optimal position.

[0116] As will further be readily appreciated by those skilled in theart, the aforementioned anchoring systems, particularly those mechanismsdepicted in FIGS. 17-19 c, such may be formed from a bio-absorbablematerial, such that the anchoring system becomes absorbed over time. Aswill be appreciated by those skilled in the art, to the extent theanchoring system is fabricated to become absorbed over time, theaforementioned discussion regarding the suture bridge may be deemedoptimal should it become necessary to maintain the suture lines at adesired location following absorption of such anchoring system.

[0117] Alternatively, the anchoring systems may be formed from anon-absorbable material such that the same remains permanently embeddedwithin the body. Moreover, it will be recognized that those mechanismsdepicted in FIGS. 17-19 c may further incorporate a tension spreadingmechanism, such a washer or mesh of fabric, that may be deployed with orintegrated as part of such anchoring system. In this respect, it will beappreciated that due to the fact that the suture holding mechanismsdepicted in FIGS. 17-19 c will necessarily have a stress and strainimparted thereto via the sutures held thereby, such plate may dissipatethe stress and strain over a larger surface area via the incorporationof such tension spreading mechanism. As per the anchor platesthemselves, such tension spreading mechanism may be formed from anabsorbable or non-absorbable material and may be formed integral with orseparate from the anchor plate.

[0118] Referring now to remaining drawings 9-15, and initially to FIG.9, there are depicted further embodiments of the present invention thatare directed to devices for attaching sutures, grafts, tissues and thelike to periosteum 36 (i.e., the thick fibrous membrane covering thesurface of bones), as well as other types of soft tissue. In thisregard, each of the embodiments herein preferably do not penetrate orotherwise become embedded within the bone 38, but rather are attachableto the periosteum 36 at a specific site thereof. However, it should beexpressly understood that such embodiments may be modified or otherwiseadapted to penetrate and become embedded within the bone 38, as may benecessary or ideal for a given medical procedure.

[0119] As will be appreciated by those skilled in the art, a widevariety of surgical procedures requiring fixation of sutures, grafts andthe like, such as transvaginal sling surgery, particularly whenperformed in accordance with the procedure depicted in FIGS. 1 and 2,frequently do not necessitate the use of devices, such as those depictedin FIG. 5, that must necessarily be screwed or anchored within the bone.Quite unexpectedly, it has recently been reported at a meeting sponsoredby the American Uro-Gynecologic Society that by utilizing the periosteum36 as a point of affixation, such affixation can be made more or equallysecure than prior art bone screws and anchors, but at the same timeachieving satisfactory, if not superior, structural support. In thisregard, deployment of such prior art bone-screw/anchor devices isgenerally considered an excessive measure insofar as such devices areknown to frequently provide an excess amount of support than what istypically required or suitable for such particular purpose. However, dueto the fact that no feasible alternative had been available until now,such bone screw and anchor devices are utilized, which can substantiallycomplicate such surgical procedures as well as cause the patient toendure unnecessary trauma, possibly delayed recovery time, and possiblyhigher risk of infection.

[0120] In the first of such embodiments depicted in FIGS. 9 and 10,there is provided an affixation device 90 comprised of at least one, andpreferably a multiplicity of piton members 92 mounted upon a basemember. Each one of the multiplicity of pitons 92, which may take theform of a hook as shown, is designed to ensnare with and become embeddedin a target site of soft tissue of the periosteum 36, as depicted inFIG. 9, but not penetrate or otherwise disrupt the outer surface of thebone 38 therebeneath. In this respect, the piton members 92 may bedesigned such that with light pressure the same only penetrate within acertain limited depth of the periosteum 36 or tissue, such that the sameprovide a moderate degree of fixation and can be easily removed, or withgreater pressure the same penetrate deeper so that the device 90 canbecome more securely embedded within the periosteum 36 or tissue to thusprovide for a more secure base or attachment. Formed on the base member94 is an attachment means, which may comprise a post or eyelet 96 asshown, to which may be attached the suture 98 or graft. As will beappreciated, the affixation device 90 need only be placed against theperiosteum 36 at a target location such that the piton members 92thereof become embedded there within. Because the piton members 92 ofthe affixation device are caused to only become embedded within theperiosteum 36, such novel fixation device may be easily removed andrepositioned as may be necessary in a given surgical procedure to insurethat an optimal degree of support or positioning is attained.

[0121] Once so optimally positioned, the suture 98 or graft may beattached to the device 90 as per conventional surgical procedures.Alternatively, due to the ease by which the affixation device 90 may bedetached and reattached, the surgeon is provided with the option ofsecuring the suture 98 or graft to such affixation device 90 andthereafter positioning the affixation device 90 at a target site forbest positioning. Advantageously, although the affixation device 90 isspecifically designed to provide for easy dislodgment and repositioning,it is believed that once the same is secured into position, due to theeventual overgrowth of tissue about such device 90, the affixationdevice will continue to provide firmer and stronger support over time.

[0122] Referring not to FIGS. 11-13, there is shown another embodiment100 of an affixation device useful in the attachment of sutures, grafts,tissues and the like to periosteum, soft tissue, and bone. In theembodiment shown, such affixation device 100 comprises a tack memberhaving a hub portion 102 and at least one, and preferably two or more,prong members 104 formed thereon. As illustrated, the implantable tack100 may be utilized to affix a graft 106 or other like tissue to theperiosteum 36 by merely interposing the graft 106 between the periosteumand the tack 100 and compressing such tack 100 there against such thatthe prongs 104 thereof extend therethrough and become embedded in theperiosteum 36 as systematically shown in FIGS. 11 and 12.

[0123] As will be recognized, the prong portions 104 of such tack 100will be specifically designed and configured to extend through a givenlayer of tissue or graft material 106 and become embedded into theperiosteum 36, but not otherwise extend to or penetrate the bone 38lying therebeneath (although the embodiment may be modified for suchapplications). It will further be appreciated that such prongs 104 mayvary in number and may take any of a variety of shapes andconfigurations necessary to achieve that end. As discussed above, it iscontemplated that the prong members 104 may be designed to penetratewithin the soft tissue, periosteum 36, or even bone 38 at specifieddepths to thus provide for selective degrees of attachment thereto. Inthis regard, it is specifically contemplated that such prong members 104may be formed to have a straight, hook or arcuate shape such that thesame facilitate the affixation of a graft 106 to the target site offixation. For example, in FIG. 12 it will be recognized that due to thearcuate shape of the prong members 104 of the implantable tack 100, whena force is applied in a direction indicated by the letter “I”, suchforce will actually cause the prong members 104 of such implantable tack100 to penetrate further within the periosteum 36 to thus cause theaffixation to become more secure with increased tension. Furthermore, byutilizing a hub member 102 as part of the implantable tack 100, asillustrated in FIG. 13, such implantable tack 100 can be easily accessedand removed in later surgical procedures. To facilitate such removal, agrip, protrusion or an aperture formed upon the hub may be provided. Forexample, it is contemplated that an attachment material, such as asynthetic mesh “extension” or sleeve, may be formed upon the hub 102.

[0124] Referring now to FIGS. 14 and 15, there is shown yet anotherpreferred embodiment 110 of the present invention that comprises a novelsurgical staple for securing sutures, tissues or grafts 112, to theperiosteum 36. As illustrated, the staple 110 is operative to penetratethrough a segment of tissue or graft 112 and become embedded within theperiosteum 36 such that the graft or tissue is caused to become affixedtherewith. As illustrated in the top view portion of FIG. 14, the stapleis operative to assume a first insertion configuration whereby theprongs 10 a, 110 b or such staple 110 are advanced through the graft 112and ultimately into the periosteum 36. Thereafter, as illustrated in thetop view of FIG. 15, the prongs 110 a, 110 b are caused to embed withinthe periosteum 36 to enhance the attachment therewith. As may benecessary for a certain application, such prongs 110 a, 110 b may evenbe caused to embed within the bone 38 lying there underneath to thusprovide a more secure attachment.

[0125] To facilitate the ability of the staple 110 to secure the graft112 to the periosteum 36 in the aforementioned manner, it iscontemplated that such staple 110 may be formed of resilient,self-expanding or self-contracting material which is biased to theoperative configuration shown in FIG. 15 such that when unconstrained,the opposed ends of the staple 110 will become further embedded into theperiosteum. Similarly, such staple may be fabricated from a plasticallydeformable material which is initially formed to assume the insertionconfiguration depicted in FIG. 14, but can subsequently be deformed toassume the operative configuration depicted in FIG. 15. As a stillfurther alternative, such staple 110 may be formed from a shape-memorymaterial, such as nitinol, which thus enables the staple to assume theinsertion configuration depicted in FIG. 14 when at room temperature,but transition to the operative, more secure configuration depicted inFIG. 15 when warmed to body temperature, as will occur such staple isdeployed. As a further advantage, to the extent it becomes necessary toremove or otherwise reposition such staple 110, it will be recognized bythose skilled in the art that removal of such staple 110 may befacilitated by merely cooling the same down by any of a variety ofwell-known methods, including applying cold saline thereto.

[0126] All of the affixation devices discussed herein, although havingwidespread applicability and substantial advantage over prior art anchordevices, and more particularly bone screws and bone anchors, areparticularly well suited in gynecologic, urologic and orthopedicsurgical applications. It is believed that such affixation devices areparticularly well suited for transvaginal sling surgery insofar as muchof the medical literature tends to indicate that in a vast majority ofpatients, the sling that is utilized in such procedures should be placedwith little to no tension at all, with the tension vector emanatingtherefrom being oriented in a direction well-suited to the piton portionof those embodying as depicted in FIGS. 6-8. Indeed, considerableauthority exists that optimal placement of the sling in transvaginalsling surgery occurs when the sling merely comes near or into contactwith the urethra. Affixation by attaching the sling merely to theperiosteum and not to the bone is thus believed to provide more thansufficient leverage or support to the sling in such applications, butyet have the further advantage of being exceptionally easy to secure andre-secure into position in a much less traumatic manner than the priorart devices.

[0127] Exemplary of such applications, as illustrated in FIGS. 23-26 isthe use of the anchor mechanisms disclosed herein in vaginofixation.Such procedure, also known as colpopexy or colporrhaphy is closelyrelated to the aforementioned surgical techniques related totransvaginal sling placement insofar as the same relies upon fixationdevices, anchors and various sling-like materials that are operative toposition and maintain the vagina in its proper orientation. In thisregard, FIG. 23 illustrates vaginal prolapse whereby the vaginal apex906 is shown extending outwardly from the vagina of a patient. SuchFigure further illustrates the relative positioning of the obturatorforamen 908, and more particularly the membrane 910 extending about theobturator foramen 908, the latter as discussed above now being widelyconsidered as the optimal zone within which to anchor slings and thelike for the treatment of urinary incontinence.

[0128] Referring now to FIG. 24, there is shown the use of an anchormechanism 900 constructed in accordance with a preferred embodiment ofthe present invention shown positioning the vagina according to itsproper orientation whereby the apex of the vagina 906 is shown extendingupwardly within the body. To achieve that end, the fixation device 900is shown securing the vaginal wall 907 to the membrane 910 extendingabout the obturator foramen. To accomplish that end, the fixation device900 is provided with a harpoon or barbed portion 904 operative to extendthrough the vaginal wall 907 and into a mass of soft tissue, such asmembrane 910. To secure vaginal wall 907 in proximity to such softtissue, there is preferably provided a large platform or head portion902 that preferably possesses sufficient surface area to hold thevaginal wall 907 according to its proper orientation such that thevaginal apex 906 remains properly positioned within the patient's body.As will be appreciated by those skilled in the art, the barbed portion904 will be configured as per any of the aforementioned embodiments suchthat the barb 904 will be operative to be inserted into a mass of softtissue into a first direction but resist rearward movement when pulledin the opposite direction. It is further contemplated that such fixationdevice 900 may be deployed through any surgical technique known in theart whether it be manually or by deployment via a surgicalinstrumentsuch as those discussed above or otherwise known in the art.For example, such fixation device 900 may be deployed via a coaxialsystem whereby a conventional guide wire is first deployed to identifythe location the obturator membrane with the device 900 being deployedthereafter. Advantageously, such procedure eliminates the risksassociated with blindly deploying such fixation device 900.

[0129] With respect to the preferred embodiments of such anchoringmechanism 900 for use in vaginofixation, two such embodiments aredepicted in FIGS. 25 and 26 respectively. Referring initially to FIG.25, (which is an enlarged figure of the fixation device depicted in FIG.24), such fixation device includes a head portion 902 having asufficient surface area operative to compress and hold a portion ofvaginal wall tissue. As will be appreciated by those skilled in the art,such head portion 902 may preferably be formed from mesh or otherbiocompatible material to facilitate the ability of the device to securea tissue mass (i.e., vaginal wall) securably into position. The anchorportion 904, as discussed above, may take any of a variety ofself-anchoring mechanisms discussed herein. As depicted, such anchorportion 904 includes a plurality of linearly-arranged arrows or V-shapedmembers operative to extend into tissue in a first direction but resistmovement in an opposite direction.

[0130] Referring now to FIG. 26, there is depicted an alternativeembodiment whereby the head portion 902 is comprised of a plurality ofwire or claw members operative to grab and securably hold a portion ofsoft tissue. The anchor portion 904 is configured as per the embodimentdiscussed above with respect to FIG. 25 and may include any anchoringmechanism operative to be advanced into tissue in a first direction butresist movement in an opposite direction, as would be achieved by thelinearly arranged arrow members as depicted. As should be readilyunderstood, however, the head portion 902 depicted in FIGS. 25 and 26may take a variety of alternative configurations as will be readilyappreciated by those skilled in the art. In this respect, so long as theanchor portion 902 is operative to attach to and securably hold a massof soft tissue, the same should be deemed to fall within the scope ofthe present invention. Also, head portion 902 may further include amember formed thereon, such as a post, eyelet, or other structure, tofacilitate manipulation or attachment thereto.

[0131] Although the invention has been described herein with specificreference to a presently preferred embodiment thereof, it will beappreciated by those skilled in the art that various modifications,deletions, and alterations may be made to such preferred embodimentwithout departing from the spirit and scope of the invention. Forexample, it will be recognized that the piton portion of any of thesurgical implants disclosed herein may take any of a variety of formssuch that the same are caused to become more thoroughly seated in aposition via the application of force in one direction, but yet becomemore easily withdrawn when pulled rearwardly in a second direction. Itis further contemplated that such embodiments may be formed fromplastically deformable or shape-memory material to thus facilitatefixation of such devices at a selected target site. Moreover, it shouldbe recognized that the affixation devices disclosed herein designed toaffix sutures, grafts, tissues, synthetic materials, and the like toperiosteum may further be modified so that the same additionallypenetrate into and become embedded within the bone lyingthereunderneath. Specifically, with respect to the embodiment depictedin FIG. 10, one or more of the hooks may be sized and adapted topenetrate into the bone, similar to the prongs formed on the implantabletack depicted in FIGS. 11-13. Likewise, the prongs of the staple elementdepicted in FIGS. 14 and 15 may be designed to penetrate and embedwithin the bone. Accordingly, it is intended that all reasonablyforeseeable additions, modifications, deletions and alterations beincluded within the scope of the invention as defined in the followingclaims.

What is claimed is:
 1. An implant for providing support to an anatomicalstructure comprising: a) an elongate segment of material having firstand second opposed ends, said segment of material being operativelypositionable adjacent said anatomical structure to be supported; and b)at least one anchor mechanism formed upon a respective one of said endsof said segment of material, said anchor mechanism being operativelyconfigured such that said anchor mechanism is advanceable through a softtissue mass in a first direction and selectively positionable at atarget site therewithin and resistant to movement in an oppositedirection.
 2. The implant of claim 1 wherein said implant includes twoanchor mechanisms attached to said segment of material, each anchormechanism being formed on a respective one of said opposed ends of saidsegment of material.
 3. The implant of claim 2 wherein said first andsecond anchor mechanisms are operatively positioned to be advancedthrough a mass of soft tissue in generally opposed or generally paralleldirections relative one another.
 4. The implant of claim 1 wherein saidsegment of material comprises a sling.
 5. The implant of claim 4 whereinsaid sling is fabricated from a material selected from the groupconsisting of synthetic material, natural material, tissue harvestedfrom a host, and combinations thereof.
 6. The implant of claim 3 whereineach anchor mechanism comprises at least one generally Y-shaped pronghaving a cord extending therethrough.
 7. The implant of claim 6 whereinsaid anchor mechanism comprises a plurality of linearly arrangedY-shaped prongs, each respective one of said plurality of prongs havinga cord extending medially therethrough.
 8. The implant of claim 3wherein at least one generally chevron-shaped prong having a cordextending therethrough.
 9. The implant of claim 8 wherein said anchormechanism comprises a plurality of linearly arranged chevron-shapedprongs, each respective one of said plurality of prongs having a cordextending medially therethrough.
 10. The implant of claim 3 wherein eachrespective anchor mechanism comprises a spiral-shaped screw.
 11. Asystem for securing a sling into affixed position within a target siteof soft tissue within the body comprising: a) an implantable slingcomprised of an elongate segment of material having first and secondopposed ends, each respective opposed end having an anchor mechanismformed thereon such that each respective anchor mechanism is advanceablethrough said soft tissue at said selected target site in a firstdirection and resistant to movement in a direction dissimilar from saidfirst direction; and b) a deployment mechanism for positioning saidanchor mechanisms of said implantable sling within said target site ofsaid soft tissue, said deployment mechanism comprising a manuallyoperable handle having a deployment member extending distally therefrom,said deployment member being detachably fastenable to a respective oneof said anchor mechanisms of said implantable sling, said mechanismfurther comprising an actuator for selectively detaching said anchormember from said deployment member of said mechanism.
 12. The system ofclaim 11 wherein said actuator is disposed within said deployment memberand operative to advance said anchor member through said soft tissue.13. The system of claim 11 wherein said deployment member has asharpened distal-most end for cutting through soft tissue.
 14. Thesystem of claim 11 wherein said actuator comprises a manuallydepressable button coupled to a shaft extending within said deploymentmember and operative to push said anchor mechanism through said softtissue.
 15. The system of claim 11 wherein said segment of material isselected from the group consisting of synthetic material, naturalmaterial, tissue harvested from a host, or combinations thereof.
 16. Amethod for surgically implanting a sling beneath an anatomical structurewithin a patient comprising the steps: a) providing an implantable slingcomprised of an elongate segment of material having first and secondopposed ends, each respective opposed end having an anchor mechanismformed thereon such that each respective anchor mechanism is advanceablethrough said soft tissue at said selected target site in a firstdirection and resistant to movement in an opposite direction; b)providing a deployment mechanism for positioning said anchor mechanismsof said implantable sling within said target site of said soft tissue,said deployment mechanism comprising a manually operable handle having adeployment member extending distally therefrom, said deployment memberbeing detachably fastenable to a respective one of said anchormechanisms of said implantable sling, said mechanism further comprisingan actuator for selectively detaching said anchor member from saiddeployment member of said mechanism; c) mounting a respective one ofsaid anchor mechanisms of said implantable sling upon said distal end ofsaid deployment member of said deployment mechanism; d) advancing saidanchor mechanism mounted upon said distal end of said deployment memberin step c) toward a site selected from the group consisting of a firstside of the obturator foramen, a first target site of rectus fascia anda first target site of pubocervical fascia of said patient andselectively detaching said anchor mechanism from said deployment membersuch that said anchor mechanism becomes embedded within a first mass ofsoft tissue; e) mounting the respective other anchor mechanism of saidimplantable sling upon said distal end of said deployment member andadvancing said respective other anchor member toward a site selectedfrom the group consisting of respective other side of said obturatorforamen, a second target site of rectus fascia and a second target siteof pubocervical fascia, said second target sites being dissimilar tosaid first target sites of rectus fascia and pubocervical fascia, suchthat said respective other anchor member extends in a directiondissimilar to said first anchor member and said segment of material ispositioned beneath the anatomical structure of said patient; and f)detaching said respective other anchor mechanism from said deploymentmember and embedding said anchor mechanism within a second mass of softtissue such that said anchor mechanisms resist movement toward oneanother and securely position said sling beneath the anatomicalstructure of said patient.
 17. The method of claim 16 wherein saidanatomical structure is selected from the group consisting of theurethra and the vaginal wall of said patient and in steps (d) and (e)said anchor mechanisms are advanced toward said sides via a singleincision made in a vagina.
 18. The method of claim 16 wherein in step(a), each respective one of said anchor mechanisms of said implantablesling comprise a plurality of linearly arranged Y-shaped prongs, eachrespective one of said plurality of prongs having a cord extendingmedially therethrough; and wherein in steps (d) and (e), said anchormechanisms are advanced by extending said cord with said generallyY-shaped anchor members formed thereon through said soft tissue.
 19. Themethod of claim 16 wherein in step (a) said anchor mechanism comprises aplurality of linearly-arranged Y-shaped members having a cord extendingmedially therethrough; and wherein in steps (d) and (e) said anchormechanisms are advanced by extending said cord with said generallychevron-shaped anchor members formed thereon through said soft tissue.20. The method of claim 16 wherein in step a), each anchor mechanismcomprises a screw-shaped mechanism; and steps (d) and (e) furthercomprise screwing said anchor mechanism into said target site withinsaid soft tissue.
 21. The system of claim 11 wherein said deploymentmember comprises an elongate sheath having a lumen extendingtherethrough, said respective one of said anchor mechanisms beingselectively positionable within said lumen and selectively deployabletherefrom.
 22. The system of claim 21 wherein said anchor mechanismcomprises a plurality of linearly-arranged anchor bodies, eachrespective one of said plurality of said anchor bodies being selectivelypositionable within and selectively deployable from said sheath.
 23. Thesystem of claim 22 wherein each respective one of said anchor bodies isoperatively transitional between a first insertion configuration whereinsaid anchor bodies are disposed within the lumen of said sheath and asecond operative configuration wherein said anchor bodies areoperatively embedded within a target site of tissue and remainsubstantially retained in position.
 24. A method of performingvaginofixation of a prolapsed or partially prolapsed vagina comprisingthe steps: a) reverting said prolapsed or partially prolapsed vagina;and b) anchoring a portion of the vaginal wall of the reverted vagina instep (a) to soft tissue positioned within the obturator foramen of saidpatient.
 25. The method of claim 24 wherein step (b) comprises thesteps: a) providing a fixation device, said fixation device having ananchor portion operative to be anchored within said soft tissue situatedabout said obturator foramen and a head portion operative to compressand be retained against said vaginal wall; and b) positioning saidfixation device such that said anchor portion is caused to extentthrough said vaginal wall and into said soft tissue situated about saidobturator foramen and said anchor portion is operative to remaincompressed against a portion of the vaginal wall.
 26. A method ofperforming colporrhphy comprising the step of anchoring a portion of thetorn vaginal wall to soft tissue positioned within the obturator foramenof said patient.